Clinical Trial: Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Sym

Brief Summary: The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in Parkinson's disease (PD) patients.

Detailed Summary:

NH004 contains the anticholinergic agent tropicamide and is delivered in a convenient product form (intra-oral dissolvable thin films) designed for the management of sialorrhea. This study is a double blind, placebo-controlled, crossover study of the safety and potential efficacy of three doses of of NH004 films for the short-term relief of the symptoms of sialorrhea in Parkinson's disease patients.

A total of up to 36 Parkinson's disease patients will be enrolled in the study in two Phases. Phase A will include 12 patients and Phase B up to 24 patients. There will be an interim analysis after conclusion of Phase A. In both phases patients will be randomized into one of four groups. Each group will have a distinctive sequence for receiving intra-oral dissolvable films of 0.3 mg, 1 mg, 3 mg of NH004, or placebo during four visits.


Sponsor: NeuroHealing Pharmaceuticals Inc.

Current Primary Outcome: Sialorrhea Visual Analogue Scale (VAS) [ Time Frame: Before and 120 min after treatment administration ]

Saliva buccal assessment was evaluated by an VAS scale before, and 15, 30, 45, 60, 90, and 120 min after treatment administration. Subjects were asked to rate how much saliva they perceived in their buccal cavity on an unmarked 0 to 10 cm line, higher scores meaning greater perceived buccal saliva levels.


Original Primary Outcome: Phase A (first 12 patients): subjective sialorrhea visual-analog scale. Phase B: sialorrhea visual-analog scale and objective saliva measurement (measured with a cotton roll). [ Time Frame: Phase A: every 15 minutes for 2 hours. Phase B: same as Phase A + one objective saliva measurement at a time point to be determined in the interim analysis. ]

Current Secondary Outcome: Percentage Change in Saliva Volume [ Time Frame: Before and 75 minutes after treatment administration ]

Saliva volume was measured at baseline and 75 minutes after treatment administration. Volumes were measured by using cotton rolls placed near each Stenton duct and below the tongue for 5 minutes; cotton rolls were centrifuged and the volume of saliva determined.


Original Secondary Outcome:

Information By: NeuroHealing Pharmaceuticals Inc.

Dates:
Date Received: September 25, 2008
Date Started: March 2008
Date Completion:
Last Updated: September 22, 2015
Last Verified: April 2013